The cardio-vascular system, when functioning properly, supplies nutrients to all parts of the body and carries waste products away from these parts for elimination. It is essentially a closed-system comprising the heart, a pump that supplies pressure to move blood through the blood vessels, blood vessels that lead away from the heart, called arteries, and blood vessels that return blood toward the heart, called veins. On the discharge side of the heart is a large blood vessel called the aorta from which branch many arteries leading to all parts of the body, including the organs. As the arteries get close to the areas they serve, they diminish to small arteries, still smaller arteries called arterioles, and ultimately connect to capillaries. Capillaries are minute vessels where outward diffusion of nutrients, including oxygen, and inward diffusion of wastes, including carbon dioxide, takes place. Capillaries connect to tiny veins called venules.
Venules in turn connect to larger veins which return the blood to the heart by way of a pair of large blood vessels called the inferior and superior venae cava.
As shown in FIG. 1, arteries 2 and veins comprise three layers known as tunics. An inner layer 4, called the tunica interna, is thin and smooth, constituted of endothelium, and rests on a connective tissue membrane rich in elastic and collagenous fibers that secrete biochemicals to perform functions such as prevention of blood clotting by inhibiting platelet aggregation and regulation of vasoconstriction and vasodilation. A middle layer 6 called the tunica media is made of smooth muscle 8 and elastic connective tissue 10 and provides most of the girth of the blood vessel. A thin outer layer 12, called the tunica adventitia, formed of connective tissue secures the blood vessel to the surrounding tissue.
The tunica media 6 differentiates an artery from a vein in that it is thicker in an artery to withstand the higher blood pressure exerted by the heart on the walls of the arteries. Tough elastic connective tissue provides an artery 2 sufficient elasticity to withstand the blood pressure and sudden increases in blood volume that occur with ventricular contractions.
When the wall of an artery, especially the tunica media 6 of that wall, has a weakness, the blood pressure can dilate or expand the region of the artery 2 with the weakness, and a pulsating sac 14 called a berry or saccular aneurysm (FIG. 2), can develop. If the walls of the arteries 2 expand around the circumference of the artery 2, this is called a fusiform aneurysm 16 (FIG. 3). If the weakness causes a longitudinal tear in the tunica media of the artery, it is called a dissecting aneurysm. Saccular aneurysms are common at artery bifurcations 18 (FIGS. 4 and 5) located around the brain. Dissecting aneurysms are common in the thoracic and abdominal aortas. The pressure of an aneurysm against surrounding tissues, especially the pulsations, may cause pain and may also cause tissue damage. However, aneurysms are often asymptomatic. The blood in the vicinity of the aneurysm can become turbulent, leading to formation of blood clots, that may be carried to various body organs where they may cause damage in varying degrees, including cerebrovascular incidents, myocardial infarctions and pulmonary embolisms. Should an aneurysm tear and begin to leak blood, the condition can become life threatening, sometimes being quickly fatal, in a matter of minutes.
Because there is relatively little blood pressure in a vein, venous “aneurysms” are non-existent. Therefore, the description of the present invention is related to arteries, but applications within a vein, if useful, are to be understood to be within the scope of this invention.
The causes of aneurysms are still under investigation. However, researchers have identified a gene associated with a weakness in the connective tissue of blood vessels that can lead to an aneurysm. Additional risk factors associated with aneurysms such as hyperlipidemia, atherosclerosis, fatty diet, elevated blood pressure, smoking, trauma, certain infections, certain genetic disorders, such as Marfan's Syndrome, obesity, and lack of exercise have also been identified. Cerebral aneurysms frequently occur in otherwise healthy and relatively youthful people and have been associated with many untimely deaths.
Aneurysms, widening of arteries caused by blood pressure acting on a weakened arterial wall, have occurred ever since humans walked the planet. In recent times, many methods have been proposed to treat aneurysms. For example, Greene, Jr., et al., in U.S. Pat. No. 6,165,193 propose a vascular implant formed of a compressible foam hydrogel that has a compressed configuration from which it is expansible into a configuration substantially conforming to the shape and size of a vascular malformation to be embolized. Greene's hydrogel lacks the mechanical properties to enable it to regain its size and shape in vivo were it to be compressed for catheter, endoscope, or syringe delivery, and the process can be complex and difficult to implement. Other patents disclose introduction of a device, such as a stent or balloon (Naglreiter et al., U.S. Pat. No. 6,379,329) into the aneurysm, followed by introduction of a hydrogel in the area of the stent to attempt to repair the defect (Sawhney et al., U.S. Pat. No. 6,379,373).
Still other patents suggest the introduction into the aneurysm of a device, such as a stent, having a coating of a drug or other bioactive material (Gregory, U.S. Pat. No. 6,372,228). Other methods include attempting to repair an aneurysm by introducing via a catheter a self-hardening or self-curing material into the aneurysm. Once the material cures or polymerizes in situ into a foam plug, the vessel can be recanalized by placing a lumen through the plug (Hastings, U.S. Pat. No. 5,725,568).
Another group of patents relates more specifically to saccular aneurysms and teaches the introduction of a device, such as string, wire or coiled material (Boock U.S. Pat. No. 6,312,421), or a braided bag of fibers (Greenhalgh, U.S. Pat. No. 6,346,117) into the lumen of the aneurysm to fill the void within the aneurysm. The device introduced can carry hydrogel, drugs or other bioactive materials to stabilize or reinforce the aneurysm (Greene Jr. et al., U.S. Pat. No. 6,299,619).
Another treatment known to the art comprises catheter delivery of platinum microcoils into the aneurysm cavity in conjunction with an embolizing composition comprising a biocompatible polymer and a biocompatible solvent. The deposited coils or other non-particulate agents are said to act as a lattice about which a polymer precipitate grows thereby embolizing the blood vessel (Evans et al., U.S. Pat. No. 6,335,384).
It is an understanding of the present invention that such methods and devices suffer a variety of problems. For example, if an aneurysm treatment is to be successful, any implanted device must be present in the body for a long period of time, and must therefore be resistant to rejection, and not degrade into materials that cause adverse side effects. While platinum coils may be having some benefits in this respect, they are inherently expensive, and the pulsation of blood around the aneurysm may cause difficulties such as migration of the coils, incomplete sealing of the aneurysm, or fragmentation of blood clots. It is also well known that the use of a coil is frequently associated with recanalization of the site, leading to full or partial reversal of the occlusion. If the implant does not fully occlude the aneurysm and effectively seal against the aneurysm wall, pulsating blood may seep around the implant and the distended blood vessel wall causing the aneurysm to reform around the implant.
The delivery mechanics of many of the known aneurysm treatment methods can be difficult, challenging, and time consuming.
Most contemporary vascular occlusion devices, such as coils, thrombin, glue, hydrogels, etc., have serious limitations or drawbacks, including, but not limited to, early or late recanalization, incorrect placement or positioning, migration, and lack of tissue ingrowth and biological integration. Also, some of the devices are physiologically unacceptable and engender unacceptable foreign body reactions or rejection. In light of the drawbacks of the known devices and methods, there is a need for more effective aneurysm treatment that produces permanent biological occlusion, can be delivered in a compressed state through small diameter catheters to a target vascular or other site with minimal risk of migration, will prevent the aneurysm from leaking or reforming.